ISO 27001
International standard for information security management systems
ISO 13485
International standard for medical device quality management systems
Quick Verdict
ISO 27001 establishes information security management for all industries, while ISO 13485 mandates quality systems for medical devices. Organizations adopt 27001 for cyber resilience and trust; 13485 for regulatory compliance, patient safety, and market access.
ISO 27001
ISO/IEC 27001:2022
Key Features
- Risk-based ISMS framework
- 93 Annex A controls in four themes
- PDCA continual improvement cycle
- Internationally recognized certification
- Technology- and industry-agnostic
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS controls for device lifecycle
- Design development planning and validation
- Traceability via medical device files
- Post-market surveillance and complaints
- Supplier evaluation and outsourcing controls
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 27001 Details
What It Is
ISO/IEC 27001:2022 is the international certification standard for establishing, implementing, maintaining, and improving an Information Security Management System (ISMS). It uses a risk-based approach to protect information assets' confidentiality, integrity, and availability across all industries and sizes.
Key Components
- **Clauses 4-10Mandatory requirements for context, leadership, planning, support, operation, evaluation, improvement.
- **Annex A93 controls in four themes (Organizational 37, People 8, Physical 14, Technological 34).
- Built on PDCA cycle; voluntary certification via accredited auditors.
Why Organizations Use It
- Risk management and resilience against breaches.
- Compliance with regulations like GDPR; competitive edge in tenders.
- Builds stakeholder trust, reduces incident costs, enables market access.
Implementation Overview
Phased: initiation, risk assessment, control deployment, audits (6-18 months). Scalable for SMEs to enterprises; requires leadership commitment, documentation, continual improvement.
ISO 13485 Details
What It Is
ISO 13485:2016, titled "Medical devices – Quality management systems – Requirements for regulatory purposes," is a certifiable international standard for QMS in medical device organizations. It ensures consistent delivery of safe devices meeting customer and regulatory needs across the lifecycle, using a risk-based approach with documented processes, validation, and traceability.
Key Components
Organized into Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement. Includes design controls, supplier oversight, process validation, medical device files, complaint handling, CAPA, and record retention tied to device lifetime. Builds on ISO 9001 but adds device-specific regulatory focus; compliance via third-party certification audits.
Why Organizations Use It
Drives market access (EU MDR, FDA QMSR 2026), reduces risks/recalls, ensures patient safety. Offers strategic benefits: supply chain assurance, faster approvals, cost savings, competitive edge through certification signaling maturity.
Implementation Overview
Phased: gap analysis, documentation, training, validation, internal audits, certification (Stage 1/2). Applies to manufacturers/suppliers globally, all sizes; 9–18 months typical, with ongoing surveillance.
Key Differences
| Aspect | ISO 27001 | ISO 13485 |
|---|---|---|
| Scope | Information security management system (ISMS) | Quality management for medical devices lifecycle |
| Industry | All industries, technology-agnostic globally | Medical devices, healthcare, suppliers specifically |
| Nature | Voluntary certification standard | Regulatory-purpose QMS standard |
| Testing | Internal audits, Stage 1/2 certification audits | Process validation, design verification, audits |
| Penalties | Loss of certification, no direct fines | Regulatory actions, market bans, recalls |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 27001 and ISO 13485
ISO 27001 FAQ
ISO 13485 FAQ
You Might also be Interested in These Articles...
Top 10 SOC 2 Mistakes Startups Make (and Fixes with Automation)
Avoid top 10 SOC 2 mistakes like scope creep & evidence gaps. See fail/pass visuals, client quotes, Vanta/Drata automation fixes for bootstrapped startups. Quic
The Tool Landscape for Reaching and Maintaining ISO 27701 Compliance
Discover the top tools for ISO 27701 compliance. Compare functionality, complexity, costs, and benefits to choose the best solution for your privacy program. Ac
NIST 800-53 Private Sector ROI Uncovered: 2025 Podcast Deep Dive into Control Family Impact on $10M+ Breach Aversions
Uncover NIST 800-53 ROI in healthcare & finance: RA, SI, IR controls break even after 1-2 incidents ($100K-$10M savings). Podcast deep dive with CISO metrics fo
Run Maturity Assessments with GRADUM
Transform your compliance journey with our AI-powered assessment platform
Assess your organization's maturity across multiple standards and regulations including ISO 27001, DORA, NIS2, NIST, GDPR, and hundreds more. Get actionable insights and track your progress with collaborative, AI-powered evaluations.
Check out these other Gradum.io Standards Comparison Pages
GLBA vs LEED
Compare GLBA vs LEED: Financial privacy safeguards meet green building standards. Master compliance, data security & sustainability for business success today!
CMMI vs MAS TRM
Compare CMMI vs MAS TRM: Discover key differences in process maturity vs tech risk controls. Boost IT governance, compliance & resilience for finance pros. Read now!
ISO 22301 vs GDPR
Discover ISO 22301 vs GDPR: Compare business continuity resilience (ISO 22301) with data privacy compliance (GDPR). Integrate for unbreakable ops & risk mastery. Learn now!